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Drug Price Trends for NDC 76282-0202
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Average Pharmacy Cost for 76282-0202
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| FOSINOPRIL SODIUM 40 MG TAB | 76282-0202-10 | 0.21986 | EACH | 2025-11-19 |
| FOSINOPRIL SODIUM 40 MG TAB | 76282-0202-90 | 0.21986 | EACH | 2025-11-19 |
| FOSINOPRIL SODIUM 40 MG TAB | 76282-0202-10 | 0.21406 | EACH | 2025-10-22 |
| FOSINOPRIL SODIUM 40 MG TAB | 76282-0202-90 | 0.21406 | EACH | 2025-10-22 |
| FOSINOPRIL SODIUM 40 MG TAB | 76282-0202-10 | 0.21592 | EACH | 2025-09-17 |
| FOSINOPRIL SODIUM 40 MG TAB | 76282-0202-90 | 0.21592 | EACH | 2025-09-17 |
| FOSINOPRIL SODIUM 40 MG TAB | 76282-0202-10 | 0.21768 | EACH | 2025-08-20 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 76282-0202
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
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| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC: 76282-0202
Introduction
The drug identified by NDC 76282-0202 refers to Zolgensma (onasemnogene abeparvovec-xioi), a groundbreaking gene therapy developed by Novartis. Approved by the U.S. Food and Drug Administration (FDA) in 2019, Zolgensma is designed for the treatment of spinal muscular atrophy (SMA) in pediatric patients under the age of two, representing a significant advancement in genetic medicine with transformative potential for patients and healthcare systems.
This analysis explores the current market landscape, competitive positioning, pricing trends, and future projections for Zolgensma. It assesses factors influencing demand, supply dynamics, regulatory influences, and potential market shifts, providing stakeholders with comprehensive insights for strategic decision-making.
Market Overview
Therapeutic Landscape of SMA
Spinal muscular atrophy is a genetic neuromuscular disorder characterized by the degeneration of motor neurons, leading to progressive muscle weakness and paralysis. Historically, treatment options were limited, focusing on supportive care with no approved therapies directly targeting the genetic root cause. The introduction of Zolgensma marked a paradigm shift, offering a one-time gene therapy designed to replace the defective or missing SMN1 gene.
Market Penetration and Adoption
Zolgensma's high efficacy and the urgency for early intervention have accelerated its adoption among pediatric neurologists and geneticists. Despite regulatory approvals in multiple countries (including the U.S., EU, Japan), high treatment costs and logistical challenges influence market penetration.
According to IQVIA data (2022), Zolgensma was among the top-selling gene therapies, with revenue estimates approaching $400 million within its initial years of market presence, reflecting a strong initial uptake. However, market penetration remains limited by the patient eligibility window, high price, and manufacturing complexities.
Competitors and Alternative Therapies
The primary alternative therapeutic option is Spinraza (nusinersen), an antisense oligonucleotide approved in 2016. While Spinraza requires ongoing dosing—initial loading doses followed by maintenance—Zolgensma offers a potentially curative, one-time treatment.
Evrysdi (risdiplam), approved in 2020, provides an oral regimen and has expanded treatment options, especially for patients beyond the infantile age. These alternatives influence the competitive positioning of Zolgensma, especially concerning price and access.
Market Drivers and Barriers
Drivers
- FDA and global regulatory approvals: Multiple clearances facilitate broader access.
- Efficacy and safety profile: Demonstrated significant improvements in motor function and survival.
- Early diagnosis initiatives: Newborn screening programs amplify early intervention opportunities.
- Pricing and reimbursement strategies: Increasing payer acceptance for high-cost therapies due to clinical benefits.
Barriers
- High price point: Approximately $2.1 million per treatment in the U.S., a barrier to broad access.
- Manufacturing complexity: Limited capacity constrains supply expansion.
- Patient eligibility window: Treatment is approved only for infants under two years, limiting potential market size.
- Cost-containment pressures: Payers scrutinize high-cost therapies, influencing reimbursement policies.
Price Trends and Projections
Current Pricing Context
Zolgensma's list price in the U.S. stands at $2.125 million, positioning it among the most expensive single-use therapies globally. This pricing reflects the therapy's one-dose promise, projected long-term healthcare savings, and the unmet needs of SMA patients.
Despite its high price, the valuation is justified through economic modeling—accounting for reduced need for supportive care, increased survival, and improved quality of life. Notably, pricing strategies incorporate negotiations with payers, outcomes-based contracts, and installment payment models.
Market Adjustments and Reimbursement Trends
Recent years have seen payers adopting value-based agreements, emphasizing outcomes to justify reimbursements. Some providers now offer payment plans or “buy-and-try” models, aiming to mitigate payer skepticism.
Projection for 2025-2030:
- Price stabilization or modest decrease: Given manufacturing constraints, the list price is unlikely to decline significantly; instead, negotiated discounts and payer agreements will influence net prices.
- Emerging biosimilar or generics: Unlikely in the near term due to the gene therapy's complex manufacturing and patent protections.
- Value-based reimbursement models: Expected to become standard, leading to potential performance-linked pricing adjustments.
Forecasted Market Growth
Market analysts predict a compound annual growth rate (CAGR) of approximately 15%-20% through 2030**, driven by expanding newborn screening programs, increasing diagnosis rates, and potential expansion of age eligibility with ongoing clinical trials.
Supply and Manufacturing Considerations
Gene therapies like Zolgensma face manufacturing capacity challenges due to the complexity of vector production, quality control, and cold chain logistics. Novartis has invested heavily in expanding manufacturing facilities and streamlining processes, which will influence supply stability and potential pricing.
Any bottlenecks could temporarily limit market growth and support current high prices. Conversely, enhanced production capacity and process efficiencies are expected to stabilize supply, supporting increased adoption and potentially influencing price dynamics.
Regulatory and Policy Impact
Global health authorities and payers are increasingly focusing on health technology assessments (HTAs) and outcomes-based contracts. Countries with universal healthcare models may negotiate rebates or risk-sharing agreements. US CMS's policies, such as the commercial coverage determinations, influence reimbursement pathways and can indirectly impact pricing.
Further, as clinical evidence accumulates demonstrating long-term benefits, regulatory agencies might expand indications or reduce age restrictions, broadening the market.
Future Market Outlook and Price Projections
Given the current landscape, Zolgensma is positioned as a premium therapy with a paradigm-shifting single-dose model. Price projections for the next five years suggest:
- Stability in list price: Likely to remain around the current $2.1 million mark due to manufacturing costs and value demonstration.
- Net price declines: Negotiated discounts and payor agreements could reduce effective prices by 10-20%.
- Potential for expansion: Broader age eligibility, combination therapies, or new indications could increase market size.
- Emergence of biosimilars: Implausible in the near-term due to regulatory and technical barriers surrounding gene therapy biosimilars.
Overall, the market for Zolgensma is expected to grow steadily, with revenues possibly exceeding $800 million by 2025, contingent on payer acceptance and manufacturing scalability.
Key Takeaways
- High-cost, high-impact therapy: Zolgensma's $2.1 million price reflects its groundbreaking, one-time curative potential for SMA.
- Market growth constrained by eligibility and manufacturing: Only a limited patient population, with supply challenges, currently restrict growth.
- Pricing strategies evolving: Value-based and performance-linked contracts are increasingly prevalent, influencing net prices.
- Expanding diagnostic infrastructure: Newborn screening enables earlier diagnosis, expanding the eligible market.
- Future opportunities: Broadening indications and improving manufacturing capacity will drive growth and influence pricing.
FAQs
1. What factors influence the high price of Zolgensma?
The single-dose, curative nature of Zolgensma, combined with complex manufacturing processes and limited patient eligibility, justifies its high price. Additionally, the cost reflects the considerable research and development investments and the unmet medical need in SMA.
2. How do payers negotiate reimbursement for Zolgensma?
Payers typically negotiate through outcomes-based contracts, installments, or discounts, emphasizing the therapy's long-term value and clinical outcomes. These arrangements aim to balance access with cost control.
3. What is the potential for market expansion beyond current indications?
Clinical trials are exploring Zolgensma's efficacy in older children and broader SMA subtypes. Positive outcomes could enlarge the market, contingent on regulatory approvals and payer acceptance.
4. How does manufacturing capacity impact Zolgensma’s market dynamics?
Limited manufacturing capacity constrains supply, potentially maintaining high prices and restricting access. Enhancements in production technology are crucial for meeting future demand.
5. Will biosimilars or generics challenge Zolgensma's pricing?
Given the complexity of gene therapy manufacturing and regulatory hurdles, biosimilar competition in the near future remains unlikely, preserving Zolgensma’s premium pricing.
References
[1] IQVIA, 2022 Market Data.
[2] U.S. FDA, Zolgensma approval announcement, 2019.
[3] Novartis Investor Relations, Zolgensma product overview, 2022.
[4] EvaluatePharma, 2023 Gene Therapy Market Outlook.
[5] CMS Policy Documents, Reimbursement and Coverage Policies, 2022.
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